Seven out of the top ten drugs are biologics. All will lose patent protection by 2020, representing an underlying pool of $60 billion in branded sales to grab for biosimilars. Are biosimilars the new El Dorado of the pharma industry? If only it was that simple to strike gold! The biosimilars market is a challenging business, where players have to deal with high R&D costs, unclear regulatory pathways, and uncertainty around business models.

First, let’s review the key characteristics of the biosimilars game. To play, large investments are required; companies need to invest $150-300 million over an eight-year time frame just to come up with a valid biosimilar compound. Next, a further $50-100 million is needed to set up reliable manufacturing capacity – unless the player can leverage existing biologic manufacturing capacity.

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Catherine Godrecka-Bareau

About this Article

Published in Issue #0117

Welcome to the January issue. Upfront investigates the relationship between pharma and patients, Donald Trump’s attack on pharma, and chemically functionalized spider silk. In our cover feature, we quiz past contributors for their opinions on 2016 – and ask them what priorities and resolutions the industry should focus on for 2017. NextGen explores modeling in bioprocess development, and in Profession, Rafaat Rahmani explains how he built an award winning global company from the ground up. We also sit down with Dominic Carolan, CEO of the National Institute for Bioprocessing Research and Training (NIBRT).